MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

Catalog Number ZVM14080

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified has not been cleared in the us but is similar to the e-luminexx vascular stent that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent are identified.(expiry date: 02/2023).

Event Description

It was reported that during stent placement procedure in the right external iliac artery lesion through contralateral approach, the device allegedly failed to deploy to the target lesion.It was further reported that the device allegedly stuck and difficult to remove.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent delivery system was not returned for evaluation and no photos were provided.Based on the information available, the investigation is closed with inconclusive results.A definite root cause of the reported incident can not be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.The instructions for use states: "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit".'pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".Regarding preparation of the device the instructions for use states that "attach the saline filled small volume (5 ¿ 10 ml) syringe to the proximal luer port which is located at the proximal end of the device.Continue flushing until saline drips from the distal tip of the catheter.Attach the saline filled small volume syringe to the t-luer adapter which is located on top of the device.Continue flushing until saline drips from the distal tip of the catheter".Regarding accessories, the instructions for use states "the bard s.A.F.E.R 6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath", "via the femoral route, insert a 0.035¿ (0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guide wire.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent are identified in d2 and g4.H10: d4 (expiry date: 02/2023), g3 h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during stent placement procedure in the right external iliac artery lesion through contralateral approach, the device allegedly failed to deploy to the target lesion.It was further reported that the device allegedly stuck and difficult to remove.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 12098786
• MDR Text Key: 259372850
• Report Number: 9681442-2021-00383
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM14080
• Device Lot Number: ANEP2930
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other